DigiFab
- Product NDC
- 50633-120
- 11-digit product format
- 506330120
- Labeler code
- 50633
- Product ID
- 50633-120_617e1370-a75c-4d9e-8465-41abfe26025d
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ovine digoxin immune fab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BTG International Inc.
- Application
- BLA103910
- Marketing category
- BLA
- Marketing start
- 2001-08-31
- Substance
- OVINE DIGOXIN IMMUNE FAB
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DigiFab
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OVINE DIGOXIN IMMUNE FAB | 40 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50633-120-11 | DigiFab | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
| 50633-120-12 | DigiFab | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OVINE DIGOXIN IMMUNE FAB | ACTIVE INGREDIENT | YB12NQZ1YN | DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| DIGOXIN | ACTIVE MOIETY | 73K4184T59 | DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50633-120 | DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250129_c05ee6a5-c98b-45f4-83fd-40781639d653.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50633-120-11 | 50633012011 | 1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12) | 2001-08-31 | 0000-00-00 | No | No | Current |
| 50633-120-12 | 50633012012 | 1 in 1 VIAL, GLASS | | | | | Historical |